The effect of ondansetron on autism

Phase 3

• Conditions: Autism Spectrum Disorder.; Autistic disorder; F84.0

• Registration Number: IRCT20200317046801N2
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 May 2020

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1-Having criteria for diagnosing autism spectrum disorder based on DSM-5 clinical interview and semi-structured K-SADS interview -.
6 -15years old
-To participate in the study with the written consent of the patient's guardian and with the patient's consent

Exclusion Criteria

Any active physical illness
There is a psychiatric diagnosis other than mental retardation
- taking any medication affecting mental status other than risperidone at least two weeks prior to the study,
A history of ondansetron allergy
Liver or heart disease or neurological or associated kidney disease
Causing any drug side effects
The patient's or guardian's unwillingness to continue to be involved in the research project for any reason

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptoms of Autism Spectrum Disorder. Timepoint: Baseline and weeks 4and 8. Method of measurement: Childhood Autism Rating Scale (CARS).;Relationship and Behavior. Timepoint: Baseline and weeks 4and 8. Method of measurement: Aberrant Behavior Checklist-Community (ABC-C).;Self-concept. Timepoint: Baseline and weeks 4and 8. Method of measurement: Self- Conception Questionnaire.;Psychiatric diagnosis of autism disorder. Timepoint: Baseline and weeks 4and 8. Method of measurement: kiddie-sads-present and lifetime version (k-sads-pl).